摘要
该文介绍涉及药物临床试验相关法规,指出随着药品监管法规和技术进步,临床试验成为中药新药研发重要环节。中药新药临床试验必须遵循《药物临床试验管理规范》要求和伦理学要求;针对中药新药临床试验的特殊性,我国构建了中医药临床研究伦理审查体系,开展中医药研究伦理审查认证。为指导中药新药临床试验开展,相关部门颁布中药新药临床试验指导系列原则,构建了中药新药评审体系和开展临床试验技术要求。为开展中药新药临床试验,从1983年开始建立"国家临床药理基地",目前已有96家中医院成为药物临床试验机构,32家中医院建有Ⅰ期病房,能够满足中药新药临床试验的开展。在长期实践中技术队伍不断发展壮大,研究经验和技术力量得到显著提升,大批专家成为我国中医临床研究中坚力量。简述了中药新药临床试验主要特点,指出要重视风险、受益评估,重视人用经验选择科学、客观、合适的有效性指标,做好中医证候疗效评价,鼓励在中药新药临床研究中采用电子化手段。通过分析近五年全国中药临床试验情况,指出中药新药临床试验的活跃度不高,中药新药创新能力不足,对中药新药临床试验投入不足,各方面能力和积极性有待提高。开展中药新药临床试验对中药产业升级和产生高级别循证医学证据具有重要意义,通过加强中药新药临床试验工作,以促进中医药事业高质量发展。
The relevant laws and regulations of drug clinical trials were introduced in this paper. It is pointed out that with drug re-gulatory laws and technological advances, clinical trials have become an important link in the development of new drugs of traditional Chinese medicines(TCM). Clinical trials of new drugs of TCM must comply with the requirement of "Good Clinical Practice for Trial on Medicinal Products". In view of the particularities of clinical trials of new drugs of TCM, China has established an ethical review system for clinical research in TCM and carried out ethical review and certification of TCM research. In order to guide the development of clinical trials of new drugs of TCM, relevant departments have promulgated a series of guidelines for clinical trials of it, and established a new review system and technical requirements for clinical trials. Since 1983, the "national clinical pharmacology base" has been established. At present, there are 96 drug clinical trial institutions and 32 phase I clinical research wards in TCM hospitals, which can meet the development of clinical trials of new drugs of TCM. In the long-term practice, the technical team has continued to grow and develop, the research experience and technical strength have been significantly improved, and a large number of experts have become the backbone of clinical research in Chinese medicine. It is pointed out that we should attach importance to risk and benefit assessment, human experience, select scientific, objective and appropriate effectiveness indexes, evaluate the efficacy of TCM syndromes, and encourage the use of electronic methods in clinical research of new drugs of TCM. Based on the analysis of clinical trials of TCM in recent five years, it is pointed out that the active degree of clinical trials of new drugs of TCM is not high, the innovation ability of it is insufficient and the ability and enthusiasm of all aspects need to be improved. It is of great significance to carry out clinical trials of new traditional Chinese medicines to upgrade the TCM industry and produce high-level evidence-based medicine evidences. The high quality development of TCM can be promoted by strengthening clinical trials of new drugs of TCM.
作者
杨忠奇
唐雅琴
杜彦萍
汤慧敏
张磊
高蕊
胡思源
唐健元
元唯安
YANG Zhong-qi;TANG Ya-qin;DU Yan-ping;TANG Hui-min;ZHANG Lei;GAO Rui;HU Si-yuan;TANG Jian-yuan;YUAN Wei-an(the First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510407,China;Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第7期1691-1695,共5页
China Journal of Chinese Materia Medica
基金
国家重点研发计划项目(2018YFC1707401,2020YFC0845300)。
关键词
中药新药
临床试验
概述
new drugs of traditional Chinese medicine
clinical trial
overview
作者简介
通信作者:杨忠奇,教授,主任医师,博士生导师,主要从事中医药临床研究/中医心血管内科,E-mail:yang_zhongqi@163.com。
